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• Firebird
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• Partner
• Nano (RD)
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• Excel
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Background breakthrough technologies
Driver of restenosis
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recoil
mechanical stabilization of acute result
Need for revascularization
neointima formation
local delivery of anti-proliferative agents
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implantation technique
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fool-proof delivery system ?
PTCA
BMS
DES
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DES ?????????
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Since DES introduction, Cardiovascular medicare
costs down
TCT2008
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Late Stent Thrombosis
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Late Stent ThrombosisFactors to Consider
Discontinuation or non-optimized antiplatelet
therapy
Late stentthrombosis
Delayedendothelialization
Late incompleteapposition
Polymer hypersensitivity/ inflammation
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Delayed endothelialization
BMS vs DES
BMS
PES
SES
BMS

• Conclusions
• BMS showed far greater endothelialization than
  DES
• Lack of coverage highlighted in areas of overlap
• Less surface coverage by endothelial cells in PES
  than SES

Finn et al. Circulation. 2005112270-278.
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Strut Coverage and Endothelization
Cypher
Taxus
Endeavor
of Struts Endothelialized
Virmani et. al. PCR. 2006.
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Directional Drug Delivery (ablumenal preference)
Labcoat JACoating Technology

• Selective coating on the outside surface of the
  stent
• Reduced drug/polymer
• Lumenal surface BMS
• Drug only where needed

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BioMatrix II Stent Platform Design

• Biodegradable Drug/Carrier
• Biolimus A9 / Poly (Lactic Acid) 5050 mix
• abluminal surface only (contacts vessel wall)
• 15 µmeter coating thickness
• degrades in 9 months releasing CO2 water

BIOFLEX I

• Stent Platform
• stainless steel (112 ?m)
• corrugated ring, quadrature-link design
• radius link enhances axial fatigue life

• Parylene Durable Primer Coating
• 5 µmeter thick, encapsulates stent
• prevents surface metal ion migration
• biostable athrombogenic

Data per NHLBI sponsored study, available from
BSI
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Conor Drug Release Technology
Mural Side
Single Drug Structure
Drug Reservoir
Simple Drug Reservoir Uniform Release
Luminal Barrier Layer
Mural Barrier
Drug A releasedto arterial wall
Multiple Drug Structures
Barrier layer
Luminal Barrier
Drug B releasedinto bloodstream
Two Drugs, Two Wells Two Directions
Two Drugs, One Well
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A Completely Polymer-Free StrategyTranslumina
YUKON ChoiceDES

• Polymer-free coating
• Unique roughened surface
• Adjustable dosage for individualized treatment
• Free choice of drugs

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MIV Polymer-free DES
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Results from Nano FIM clinical study Minimal
Lumen Diameter at 6-8 Months
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Results from Nano FIM clinical study LL at 6-8
Months
NanoTM
PartnerTM
0.37
0.30
0.34
0.26

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OCT??????????????,??????,???????
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Design Principle of EPC Capturing and Drug
Eluting Combination Stent
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EPC Capturing and Drug Eluting Combination Stent
RAPAMYCIN
Outer surface-Rapamycin
Inner surface-CD34 antibody
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Adsorption principal of CD34 antibody on the
stents surface
PatentsPCT/CN2007/002964
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The activity of CD34 antibody of the inner
surface
BMS
Combination stent
The inner surface of Combination stent
Photo by microscope
Immerse in KG-1a cell suspension stained by
DAPI (CD34 Cell,ATCC)
The inner surface of BMS
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Endothelium Appraisement SEM Morphology on the
7th day
BMS CD34 stent
Combination stent
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Animal Experimental Results in porcine-QCA
Plt0.05
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AMS-Magnesium Absorbable Stent
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REVA Bioresorbable Coronary Stent
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BVS-Bioaborbable Everolimus Stent
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ABSORB FIM trial 12 month data N30 MACE 3.3 (1
MI, 0 TLR) No late stent thromboses 6 month
in-stent late loss was 0.440.35 mm Neointimal
area was small 0.30 0.44 mm2
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FDA request for optimal duration for
blood-thinning therapy post DES stenting

• A 100 million dollars study will be launched by
  eight medical companies to determine how best to
  protect patients from clots after DES stenting
• The four-year, 20,000-patient study is intended
  to determine whether stent patients can safety
  stop blood-thinning treatment after one year, or
  if they better to remain on the medication for at
  least 2.5 years after stenting.

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OCT
Cypher has even after 2 years high number of
uncovered Stent struts ! Stoppingof Clopidogrel
is a potential risk for a late Stent Thrombosis
for Cypher! Polymer-free is the key!
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Infraredx

• a NIR spectroscopy system to identify plaque
  composition

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